U.S. Pat. Nos. 7,304,036 and 7,371,727 disclose peptides that act as agonists of the guanylate cyclase C (GC-C) receptor for the treatment of gastrointestinal disorders. One particular peptide disclosed is linaclotide, which consists of the following amino acid sequence: Cys Cys Glu Tyr Cys Cys Asn Pro Ala Cys Thr Gly Cys Tyr (SEQ ID NO: 1). The '036 and '727 patents also disclose methods for preparing linaclotide and related peptides. The contents of these patents are incorporated herein by reference in their entirety.
There remains a need for improved formulations of linaclotide, and pharmaceutically acceptable salts thereof, having improved stability and performance properties.
The present invention seeks to provide such improved formulations of linaclotide, as well as processes for making the formulations and methods of treating gastrointestinal disorders by administering the formulations.